GovWire

Field Safety Notices: 28 October to 1 November 2024

Medicines Healthcare Products Regulatory Agency

November 5
09:17 2024

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Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Abiomed: Impella heart pump

2 April 2024

Intracardiac Circulatory Assist Axial Pump Cath.

Model: all models of Impella heart pumps

MHRA reference: 33776034 2024/002/025/601/001

Arjo: IndiGo Intuitive Drive Assistance

September 2024

Accessory for basic electric hospital beds

Model: INDI-XXX

MHRA reference: 33615874 2023/012/013/601/033

Becton, Dickinson and Company: See comments box

6 November 2024

See comments box

MHRA reference: 33783989 2024/010/031/601/058

Bordier Affinity Products: As described in the FSN-240829UK Attached

29 August 2024

MHRA reference: 33744394 2024/010/028/601/045

Dutch Ophthalmic Research Center (DORC): Silicone Oil

September 2024

Vitreous humour replacement medium, intraoperative

MHRA reference: 33772908 2024/010/015/601/033

Getinge: Universal Remote Control

21 October 2024

Medical device remote control keypad

Model: 100925A0

MHRA reference: 33723020 2024/010/025/601/079 - Customer letter

MHRA reference: 33723020 2024/010/025/601/079 - Reply form

HYALTECH: Visthesia 1.5%

10 October 2024

Ophthalmic Viscosurgical Devices

MHRA reference: 33728193 2024/010/024/601/003

SIEMENS Healthineers: Atellica CH ?2-Microglobulin (B2M)

October 2024

See section 8

MHRA reference: 33768573 2024/010/029/601/126

Smiths Medical: Tracheal Tube Reusable Introducer and Guides

4 November 2024

Endotracheal tube introducer/guide, reusable

Model: See FSN

MHRA reference: 33768404 2024/010/030/601/028

TAEWOONG Medical : Niti-S Tracheobronchial Uncovered Stent

14 March 2024

Bare-metal tracheal/bronchial stent, sterile

Model: BRxxxxW

MHRA reference: 33728108 2024/003/014/601/001

Updates to this page

Published 5 November 2024

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